COLLABORATIVE OCULAR MELANOMA STUDY

眼部黑色素瘤合作研究

• 批准号: 3559229
• 负责人: PETER LIGGETT
• 金额: $ 7万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-09-30 至 1995-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559229
• 关键词: cooperative study; eye disorder diagnosis; eye neoplasms; human mortality; human subject; human therapy evaluation; longitudinal human study; melanoma; metastasis; neoplasm /cancer diagnosis; neoplasm /cancer radiation therapy; patient care management; prognosis; radiation hazard; retina disorder; vision tests; visual perception

The proposed study is a multicenter, randomized, controlled clinical trial designed to compare enucleation of eyes with choroidal melanomas with irradiation on the basis of survival after diagnosis and treatment. Candidates for the study will be newly diagnosed cases with choroidal melanoma in one eye greater than 3 mm in height and up to 18 mm by 8 mm in size and with no evidence of metastatic disease who are 21 years of age or older. Informed consent will be obtained from all patients prior to randomization. All patients will be followed for a minimum of ten years or until death. The outcome of primary interest is death from all causes. Secondary outcomes will include death from cancer, whether metastatic or not, and diagnosis of other tumors. Complications of irradiation and changes in visual acuity will be documented and monitored carefully throughout follow-up. The study will be conducted in clinical centers located throughout the United States which draw patients from the major population centers; a Coordinating Center, a Fundus Photograph Reading Center; a Pathology Center; and a Sonography Center. Each clinical center will be expected to enroll at least 12 elegible patients each year. The study will be directed by an Executive Committee consisting of 12 to 15 study investigators and a Stering Committee to deal with day-to-day operational decisions. An independent Data and Safety Monitoring Committee will be responsible for assuring the ethical conduct of the study and for reviewing the accumulating data on a regular basis for evidence of adverse or beneficial effects of therapy. The intention of the investigators is to collect and analyze data of high quality which will provide a conclusive answer to the question of therapeutic preference in the management of patients with choroidal melanomas. Standardized clinical and data collection procedures will be employed, and standardized forms will be used in all centers. Central training and certification of all study staff will be required.

本研究是一项多中心、随机、对照临床试验 旨在比较患有脉络膜黑色素瘤的眼球摘除术与 在诊断和治疗后生存的基础上进行照射。 该研究的候选人将是新诊断的脉络膜 单眼黑色素瘤，高度大于3 mm，最大18 mm × 8 mm， 大小和没有转移性疾病的证据谁是21岁或 老了 将在以下时间之前获得所有患者的知情同意书： 随机化 所有患者将接受至少10年的随访， 直到死亡 主要关注的结局是各种原因导致的死亡。 次要结局将包括癌症死亡，无论是转移性还是 没有，以及其他肿瘤的诊断。 辐射的并发症和 将记录并仔细监测视力的变化 整个后续。 该研究将在全国各地的临床中心进行 从主要人口中心吸引患者的美国; 协调中心，眼底照片阅读中心;病理学 中心;和一个超声波中心。 预计每个临床中心将 每年至少招募12名合格患者。 该研究将指导 执行委员会由12至15名研究者和 处理日常业务决策。 一个 独立的数据和安全性监查委员会将负责 确保研究的伦理行为，并审查 定期积累数据，以证明不利或有益的 治疗的效果。 调查人员的目的是收集和分析高风险的数据。 质量，这将提供一个决定性的答案， 脉络膜视网膜病变患者的治疗偏好 黑素瘤。 标准化的临床和数据收集程序将 所有中心都将使用标准化的表格。 中央 需要对所有研究工作人员进行培训和认证。